BS EN ISO 5367:2014
$189.07
Anaesthetic and respiratory equipment. Breathing sets and connectors
| Published By | Publication Date | Number of Pages |
| BSI | 2014 | 48 |
*This International Standard specifies basic requirements for breathing sets and breathing tubes intended to be used with anaesthetic breathing systems, ventilator breathing systems, humidifiers or nebulizers. It applies to breathing sets and breathing tubes and patient end adaptors supplied already assembled and to those supplied as components and assembled in accordance with the manufacturer’s instructions.
This International Standard is applicable to breathing sets which include special components (e.g. water traps) between the patient end and machine end which are supplied already assembled.
This International Standard is not applicable to breathing sets and breathing tubes for special purposes.
EXAMPLE 1 Ventilators having special compliance, pressure or breathing frequency requirements.
EXAMPLE 2 High Frequency Oscillatory Ventilation, (HFOV) or High Frequency Jet Ventilation (HFJV).
EXAMPLE 3 Breathing sets and breathing tubes with special connectors for neonatal ventilation.
Provision is made for coaxial and related bifurcated, double-lumen, or multiple-lumen breathing sets and breathing tubes suitable for use with patient end adaptors.
NOTE 1 Examples of various types of breathing sets with patient end adaptors are depicted in Annex A.
Requirements for exhalation valves, exhaust valves, adjustable pressure-limiting (APL) valves, heat and moisture exchangers (HMEs), breathing filters, and reservoir bags, if provided, are not covered by this International Standard.
NOTE 2 ISO 80601-2-12, ISO 80601-2-13, ISO 9360-1[3], ISO 23328-2[4], and ISO 5362[1] cover these.
NOTE 3 Certain aspects of heated-wire breathing tubes are discussed in ISO 8185[2].
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 9 | Foreword |
| 10 | Introduction |
| 11 | 1 Scope 2 Normative references |
| 12 | 3 Terms and definitions |
| 14 | 4 General requirements 4.1 Risk management 4.2 Usability |
| 15 | 4.3 Clinical evaluation 4.4 Biophysical or modelling research 4.5 Test methods 4.6 Recommended service life 5 Specific requirements 5.1 Materials 5.2 Length |
| 16 | 5.3 Means of connection |
| 17 | 5.4 Leakage 5.5 Resistance to flow |
| 18 | 5.6 Compliance |
| 19 | 6 Prevention of electrostatic charges 7 Requirements for breathing sets and breathing tubes supplied sterile 7.1 Sterility assurance 7.2 Packaging of breathing sets and breathing tubes supplied sterile |
| 20 | 8 Marking 8.1 General 8.2 Marking of breathing sets and breathing tubes 8.3 Marking of packages |
| 22 | 8.4 Information to be supplied by the manufacturer |
| 23 | Annex A (informative) Rationale |
| 33 | Annex B (informative) Hazard identification for risk assessment |
| 34 | Annex C (normative) Test for security of attachment of plain end to conical connector |
| 35 | Annex D (normative) Test for security of attachment of adaptor to breathing tube |
| 36 | Annex E (normative) Test for leakage |
| 38 | Annex F (normative) Measurement of resistance to flow |
| 41 | Annex G (normative) Test for increase in flow resistance with bending |
| 43 | Annex H (normative) Test for compliance |
| 45 | Bibliography |
